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中文摘要：
目的探讨美国临床实验室标准化协会（CLSI）发布的EP12-A2《定性试验评价方法用户协议：提议指南》，在血站血液检测实验室酶联免疫吸附试验（ELISA）性能确认过程中的适用性。方法参照CLSI发布的EP12-A2指南，对本血站血液检测实验室现用的定性ELISA试验进行性能确认，包括4种试验的重复性研究和8种试验性能比较研究。结果重复性研究：乙型肝炎表面抗原（HBsAg）B和丙型肝炎抗体（抗-HCV）B试验均能够选定临界值分析物浓度（C50）样本。2种试验（C50）＋20％浓度的样本产生阳性结果数≥95％，同时（C50）-20％浓度的样本产生阴性结果数≥95％；梅毒抗体（抗-TP）B和抗-HCVA试验由于采用固定临界值（cutoff），均无法找到接近C50的样本，故无法得到重复性研究的结果。试验性能比较研究中，检测具有明确诊断的样本时，8种ELISA试验的灵敏度和特异性均较高；同一项目4组试验的灵敏度和特异性差异均无统计学意义。检测未知诊断结果样本时，同一项目4组试验一致率均〉99％。结论使用EP12-A2方案，对本实验室采用的4种ELISA试验进行重复性确认，8种ELISA试验进行性能一致性确认。部分试验由于cutoff设置方式原因，不适宜采用EP12-A2中重复性研究方案进行方法精密性评估。试验性能比较研究适用于所有定性试验性能确认活动。
英文摘要：
Objective To evaluate the applicability of EP12-A2 document protocols issued by United States of America Clinical Laboratory Standards Institute （CLSI） in the performance qualification of ELISA method in the blood screening laboratory. Methods According to the released CLSI EP12-A2 document protocols, all qualitative tests used at present were made performance validation, including research on the reproducibility for four assays and comparison for eight assays with each other. Results the reproducibility study：The sample with C50 concentration for HBsAg B assay and anti-HCV B assay was screen out successfully. For both assays, the cutoff （C50） ＋ 20% concentrations of samples produced positive results count ≥95% ,and the cutoff （C50） -20% concentrations of the Samples produced negative results count ≥ 95%. Anti-TP B assay and anti-HCV A assay were unable to find the sample with C50 concentration due to fixed cutoff,so it couldn＇t obtain reproducible results. The comparison study： Using samples with known clinical diagnosis result, sensitivity and specificity of 8 ELISA assays were high. There were no significant differences in sensitivity and specificity between the two kind of HBsAg assay （ 1 group）, and the same as anti-HCV, anti-HIV, anti-TP. Conclusion It demonstrated that in the study of reproducibility study of 4 ELISA assays and 8 ELISA assays of performance validation study,part of the assays were not suitable for EP12- A2 reproducible research method for precision assessment because of the cutoff setting means in blood screening laboratory. The protocols used in assay performance comparison in EP12-A2 documents were applied in all qualitative tests performance validation.
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